Facial ageing Not Applicable
Conditions
Interventions
Study population: Male or female subjects between the ages of 25 and 75 years of age with one or more of the following changes:
1. Mild to significant facial volume deficit (mid-face a
Sponsors
Sinclair Pharma
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female subjects between the ages of 25 and 75 years of age 2. Subject seeking an aesthetic improvement of her/his face with a poly-L-lactic acid dermal filler product 3. Any one or more of the following clinician-assessed criteria: 3.1. Mild to significant volume deficit in the mid-face (score of 2-4 on the designated photographic assessment scale) 3.2. Moderate to severe nasolabial folds (3-4 on the designated photographic assessment scale) 3.3. Mild to moderate jawline ptosis as assessed (score of 1-2 on the designated photographic assessment scale) 3.4. Minimal to severe temporal hollowing (2-4 on the designated photographic assessment scale) 4. Subject having given freely and expressly his/her informed consent 5. Subject willing to have photographs of the face taken and who is willing to provide approval for the use of their study data including photographs 6. Subjects must be willing and able to comply with protocol requirements, instructions, and protocol-stated restrictions and be likely to complete the study as planned. 7. Women of childbearing potential should be using a medically accepted contraceptive regimen for at least 12 weeks prior to study entry and over the entire study duration 8. Subjects willing to commit to having no further facial aesthetic treatments that will affect the appearance of the study treatment areas for the duration of the study period, including follow-up
Exclusion criteria
Exclusion criteria: 1. Subjects who, in the months prior to their enrolment assessment have undergone any of the following treatments in the facial region to be treated: 1.1. 3 months prior: 1.1.1. Mesotherapy 1.1.2. Resurfacing (e.g., laser, radio frequency, dermabrasion, or chemical peel) 1.2. 6 months prior: 1.2.1 Temporary filler (e.g., Ha, CaHA, PCL) 1.2.2. Neuromodulator injections 1.3. 12 months prior: 1.3.1. Cosmetic facial plastic surgery (other than rhinoplasty) 1.3.2. Tissue grafting (e.g., fat injections) 1.3.3. Tissue lifting implants (e.g., threads, barbs) or other implants 1.3.4. Augmentation with semi-permanent filler (e.g., PLLA) 2. Subjects who have received treatment with a permanent, silicone or PMMA filler in the region of the face to be treated 3. Subjects who have received any other facial aesthetic procedures that will affect the appearance of the region of the face to be treated, at any time during the study period 4. Pregnant women or nursing women or women planning to become pregnant during the study 5. Subject, who is likely to become pregnant during the course of the study, who is not using or has changed or started their medically accepted contraceptive regimen or any other hormonal treatment during the 12 weeks prior to study entry 6. Subject with a known history of, or susceptibility to, keloid formation or hypertrophic scarring 7. Subject suffering from a severe or progressive disease or any other pathology that may interfere with the evaluation of the study result and/or subject safety 8. Subject with scar(s), mole(s), tattoos, permanent make-up, facial hair, or anything in the studied zones which might interfere with the evaluation 9. Subject with a known history of or suffering from autoimmune disease and/or immune deficiency unless stable and controlled by medication and will not interfere, at the interpretation of the investigator, with the study objectives in terms of efficacy and safety 10. Subject with porphyria 11. Subject with a known history of streptococcal disease (recurrent throat infections, acute rheumatic fever with or without cardiac involvement) 12. Subject with a known history of precancerous lesions/skin malignancies 13. Subject with a known history of severe allergy or anaphylactic shock 14. Subject with a known bleeding disorder or is receiving medication that will likely increase the risk of bleeding during treatment 15. Subject using medication such as aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs), antiplatelet agents, thrombolytics or anticoagulants within one week prior to injection visit and 1 month after treatment 16. Subject suffering from an active disease such as inflammation, infection, tumours, psoriasis, allergic edema, inflammatory and/or infectious cutaneous disorders (herpes, acne, rosacea...) on the face within 6 months of the study entry 17. Any medication which may interfere, at the interpretation of the investigator, with the study objectives in terms of efficacy and safety. 18. Subject suffering from a severe or prog
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improved aesthetics and correction of skin depressions and contour in the treated area(s) of the face measured using the Global Aesthetic Improvement Scale (GAIS) at 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Improved aesthetics and correction of skin depressions of the treated area(s) of the face measured using the Global Aesthetic Improvement Scale (GAIS), mid-face volume deficit scale, and photographic scales for the assessment of nasolabial folds, photographic scales for the assessment of jawline sagging, photographic temporal hollowing assessment scale, as appropriate, at earlier (2 and 4 months) and later timepoints in months 6, 12, 18, and 25 after injections 2. Patient-reported satisfaction with the aesthetics and correction of skin depressions of the treated area(s) of the face measured using treatment satisfaction questionnaires at earlier (2 and 4 months) and later timepoints in months 6, 12, 18, and 25 after injections 3. Safety measured through the collection of adverse events (AEs) and injection site reactions (ISR) recorded in subject diaries at 2 weeks, and 2, 4, 6, 12, 18 and 25 months after injections | — |
Countries
Spain
Contacts
Public ContactStuart Boothman
Outcome results
None listed